Effect of Metformin on Carotid Atherosclerosis for Non-diabetic Patients With PsA (CAMPA Study)

NCT05988684 | Completed Phase 4

• 1 other identifier: CAMPA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Psoriatic arthritis (PsA) is a common chronic inflammatory disease with a prevalence up to 670 every 100,000 subjects. Patients with PsA has an increased risk of cardiovascular disease (CVD) which is one of the major causes of death. The investigators hypothesize that metformin in combination of a treat-to-target (T2T) strategy aiming at tight disease control is more effective in preventing progression of subclinical arthrosclerosis than T2T strategy alone in non-diabetic PsA patients. Objective: To investigate the vascular effects of metformin in PsA patients without diabetes mellitus. The metabolic and anti-inflammatory roles of metformin will also be explored. Study design: This is a 1-year, single-centered, pilot, open-labelled, randomized controlled trial. A total of 24 enrolled patients with PsA being followed at the Prince of Wales Hospital rheumatology clinics will be recruited and randomized to either metformin group or control group in a 1:1 ratio. Participants randomized to the metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day (one with the morning meal, one with the evening meal) to reduce gastro-intestinal adverse events. Expected outcomes: The data from this study will support that there will be significant difference in the proportion of subjects with carotid plaque progression between the metformin group and control group over a period of 1 year.

Conditions

PsA (Psoriatic Arthritis)

Outcome Measures

Primary Outcomes (1)

• Difference in the proportion of subjects with carotid plaque progression between the metformin group and control group

  Carotid plaques will be assessed at baseline and 12 months using a high-resolution B mode ultrasound machine (Philips EPIQ7) by a single experienced sonographer blinded to all clinical information using a 30-MHz linear vascular probe (Philips L12-3 broadband linear array transducer). Plaque progression is defined as an incident plaque in a segment without plaque before or an increase in number of plaque. The primary outcome will be analyzed using multivariate logistic regression model. In univariate analysis, potential covariates including age, sex, traditional cardiovascular risk factor, disease activity and use of statin or biologic or targeted synthetic disease modifying anti-rheumatic drugs would be included. Variables which are significantly different between the two groups in the univariate analyses and are biologically plausible will be adjusted in the multivariate logistic regression model to confirm the metformin treatment effect.

  1 year

Secondary Outcomes (11)

• Changes in mean carotid intima-media thickness (CIMT) between the two groups

  1 year

• Changes in carotid total plaque area (TPA) between the two groups

  1 year

• Changes in coronary artery calcification (CAC) score

  1 year

• Changes in coronary plaque volume

  1 year

• Changes in coronary stenosis level

  1 year

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin group will be instructed to take metformin

Drug: Metformin

control

NO INTERVENTION

Standard treatment and Follow-up, no metformin

Interventions

Metformin DRUG

Patients randomized to metformin group will be instructed to take 500 mg metformin daily for 1 week before titrating up to twice a day

Also known as: Glucophage

Metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fulfill the ClASsification criteria for Psoriatic ARthritis (CASPAR),
• are over 18 years old,
• have a Framingham Risk Score ≥ 10% (i.e. moderate to high CV risk) and
• have carotid plague on previous ultrasound.

You may not qualify if:

• have prior therapy with metformin during the last 6 months;
• have pre-existing diabetes as defined by the World Health Organization (WHO) criteria:
• fasting plasma glucose values of ≥ 7.0 mmol/L,
• h post-load plasma glucose ≥ 11.1 mmol/L,
• HbA1c ≥ 6.5% or
• a random blood glucose ≥ 11.1 mmol/L);
• have liver impairment: ALT more than or equal to 2.5×upper limits of normal;
• have renal impairment: serum creatinine levels more than or equal to 135µmol/L in males and more than or equal to 110µmol/L in females;
• have had ACS within the previous 3 months;
• have New York Heart Association functional class 3 or 4 heart failure;
• have uncontrolled angina;
• have 70% or more stenosis on initial CCTA;
• have clinically relevant current malignancy;
• are pregnant; breastfeeding or of childbearing potential but unwilling to use adequate contraception;
• are unable to give written informed consent;

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 14, 2023
• Study Start: August 30, 2023
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the final manuscript
• Access Criteria: For research purpose

Locations

HK (1)